Patient Information Leaflet

ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER 20 mg + 12.5 mg tablets

enalapril maleate and hydrochlorothiazide
Generic medicine
Please read this leaflet carefully before taking this medicine because it
contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER is and what it is used for
What you need to know before taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER
How to take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER
Possible side effects
How to store ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER
Contents of the pack and other information

1. What ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER is and what it is used for

ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER contains two active substances: enalapril maleate and hydrochlorothiazide.
Enalapril belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors). ACE inhibitors work by causing relaxation of the blood vessels, thereby facilitating blood flow through them. ACE inhibitors are used to treat high blood pressure (hypertension). Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It works by stimulating the kidneys to produce more urine (diuretic effect), thus reducing blood pressure (antihypertensive effect).
ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER is used to treat high blood pressure and is indicated in patients whose blood pressure is not adequately controlled with enalapril maleate or hydrochlorothiazide given alone.

2. What you need to know before taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER

Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER

if you are allergic to the active substances (enalapril maleate and hydrochlorothiazide) or to other sulfonamide-derived medicines (chemically related
to hydrochlorothiazide), or to any of the other ingredients of this medicine
(listed in section 6);
if you have had an allergic reaction causing swelling of the hands, feet, ankles, or even face, lips, tongue and/or throat, leading to difficulty in swallowing or breathing (angioedema) after taking ACE inhibitors;
if you suffer from hereditary angioedema (due to a familial predisposition);
if you suffer from idiopathic angioedema, i.e. angioedema of unknown cause;
if you have severe kidney problems (severe renal failure);
if you are unable to urinate (anuria);
if you are in the second or third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
if you have severe liver problems (severe hepatic insufficiency);
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren (see section “Other medicines and ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER”);
if you are being treated with sacubitril/valsartan, a medicine for heart failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER:

if you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER.
If you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Enalapril and Hydrochlorothiazide Alter, consult a doctor immediately.
In particular, talk to your doctor or pharmacist before taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER if:
you are taking medicines that increase urine production (diuretics), are on a low-salt diet, or have had vomiting or diarrhoea. In these cases, you are at risk of excessive drop in blood pressure (hypotension), which may manifest as weakness or dizziness. Your doctor will prescribe regular monitoring of electrolyte levels in your blood;
you have disorders of blood flow to the heart (ischaemic heart disease) or brain (ischaemic cerebrovascular disease), or other heart problems, with or without kidney problems. In such cases, excessive lowering of blood pressure may be particularly dangerous. If you experience symptoms of hypotension during treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER, lie down and contact your doctor;

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inform your doctor if you are taking a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan), used in patients with heart failure, or racecadotril, used in patients with acute diarrhoea;
you are taking any of the following medicines used to treat high blood pressure:
an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER”;
you are at risk of increased potassium levels in the blood (hyperkalaemia) due to:
renal failure, worsening kidney function, age over 70 years, diabetes, dehydration, acute heart failure causing inadequate blood pumping by the heart, increased blood acidity (metabolic acidosis);
concomitant use of medicines that promote urine elimination while preserving potassium (potassium-sparing diuretics, e.g. spironolactone, eplerenone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes, or if you are taking other medicines that may increase potassium levels in the blood (e.g. heparin [a medicine used to prevent blood clots], products containing trimethoprim, such as co-trimoxazole [medicines used to treat infections]) (see section “Other medicines and ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER”). In such cases, your doctor will frequently monitor your blood potassium levels;
you suffer from narrowing (stenosis) of the aortic artery or have thickening of the heart walls (hypertrophic cardiomyopathy);
you suffer from severe heart problems (severe heart failure);
you have kidney problems, e.g. narrowing (stenosis) of one or both renal arteries, as there is an increased risk of hypotension and renal failure. In such cases, your doctor will closely monitor your kidney function;
you have recently undergone a kidney transplant. In this case, use of this medicine is not recommended;
you are undergoing dialysis (blood purification therapy) due to renal failure. In this case, your doctor will consider an alternative treatment (see section “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER”);
you have liver problems or suffer from a disease that could lead to destruction of liver cells (progressive hepatopathy) (see sections “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER” and “Stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER and inform your doctor if”);
you have chronic degenerative liver disease (liver cirrhosis), produce large amounts of urine, do not take adequate oral electrolytes, or are being treated with corticosteroids or adrenocorticotropic hormone (hormonal medicines).

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In such cases, the risk of low blood potassium levels (hypokalaemia) is highest;

you suffer from a connective tissue disease affecting blood vessels, are taking immunosuppressive medicines, suffer from gout or are taking allopurinol (used to treat gout) or procainamide (used to treat heart rhythm disorders), or have a combination of these risk factors, especially if you also have kidney problems. In such cases, severe infections may occur that may not respond to antibiotic therapy. If you need to take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER under these conditions, your doctor will prescribe specific blood tests. Report any signs or symptoms of infection to your doctor;
you have diabetes and are taking oral antidiabetic medicines or insulin. In this case, your doctor will advise blood tests to monitor glucose levels, especially during the first month of treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER, and may adjust the dose of your antidiabetic medicines;
you are taking lithium (a medicine for treating mood disorders) (see section “Other medicines and ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER”);
you are of Black race. ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER may be less effective in lowering blood pressure in Black patients compared to non-Black patients. In addition, you may have a higher risk of developing angioedema;
you have developed a persistent dry cough for a long time after starting treatment with an ACE inhibitor;
if you have a history of allergies or bronchial asthma, as sensitivity reactions may occur with the use of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER;
if you suffer from a disorder called systemic lupus erythematosus (an autoimmune disease), which may develop or worsen with use of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER;
if you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur from a few hours to weeks after taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER. If untreated, this increase may lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition.

If you are about to undergo any of the following procedures, inform your doctor that you are
taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER:

any surgical procedure or if you are to receive anaesthetic therapy;
a treatment called dextran-sulfate LDL (low-density lipoprotein) apheresis, to remove cholesterol from the blood using machines. Your doctor may interrupt treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER to prevent a possible allergic reaction;
a treatment to reduce the effects of an allergy, e.g. following an insect sting (desensitisation therapy). If you take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER during this treatment, you may experience a severe allergic reaction; therefore, temporary interruption of therapy is advisable;
you need to undergo tests to assess parathyroid gland function. Consult your doctor, who will advise you to stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER before undergoing this test.

Stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER and inform your
doctor if you experience:

swelling of the hands, feet, ankles, or face, lips, tongue and/or throat with difficulty in swallowing or breathing (angioedema);
yellowing of the skin or whites of the eyes (jaundice), indicating liver problems or increased liver enzyme (transaminase) levels in the blood;
increased blood urea nitrogen and creatinine levels, which may suggest possible renal artery stenosis;
increased calcium levels in the blood (hypercalcaemia).

During treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER, an electrolyte imbalance may occur, manifesting with signs and symptoms such as:

dry mouth, thirst, weakness, pathological state of deep sleep (lethargy), drowsiness, restlessness, muscle pain or cramps, muscle fatigue, low blood pressure, reduced urine output, increased heart rate (tachycardia), and gastrointestinal disturbances such as nausea and vomiting. In such cases, contact your doctor promptly. This medicine must be used under regular medical supervision. Therefore, strictly follow all laboratory tests and check-ups as prescribed by your doctor.

Children and adolescents
The use of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER is not recommended in children due to lack of data on safety and efficacy.
Other medicines and ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, consult your doctor or pharmacist if you are taking:

an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also section “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER” and “Warnings and precautions”). Your doctor may consider it necessary to adjust the dose and/or take other precautions;
other medicines that lower blood pressure (antihypertensives), including vasodilators, nitroglycerin and other nitrates, as excessive lowering of blood pressure may occur;
lithium, used to treat certain mood disorders, as excessive increase in lithium concentration in the blood and consequent lithium toxicity may occur;
medicines that promote urine elimination while preserving potassium (potassium-sparing diuretics, e.g. spironolactone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes, or other medicines that may increase potassium levels in the blood (e.g. heparin [a medicine used to prevent blood clots], products containing trimethoprim such as co-trimoxazole [medicines used to treat infections)] (see section “Warnings and precautions”);
medicines that promote diuresis (diuretics), such as thiazides or loop diuretics, as they may cause a reduction in blood pressure;
anaesthetics, antipsychotics and tricyclic antidepressants (used to treat mental disorders), as further reduction in blood pressure may occur;
medicines acting on the autonomic nervous system (sympathomimetics) such as ephedrine, pseudoephedrine, salbutamol found in some nasal decongestants, cough and cold medicines, asthma treatments, treatments for low blood pressure and cardiac problems. These medicines may reduce the antihypertensive effects of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER;
insulin or other oral antidiabetic medicines. Blood glucose levels should be closely monitored, especially during the first weeks of treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER and in patients with kidney problems;
medicines used to treat stiffness and inflammation associated with painful conditions, particularly those affecting muscles, bones and joints, including:
gold-containing medicines administered by injection, e.g. sodium aurothiomalate, as they may cause facial flushing, nausea, vomiting and low blood pressure when taken with ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER;
non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, as they may reduce the effectiveness of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER, increase blood potassium levels and worsen kidney function;
carbenoxolone (a medicine used to treat stomach problems such as ulcers), kaliuretic diuretics (e.g. furosemide) or excessive use of laxatives. Taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER with these medicines may further reduce potassium and/or magnesium levels in the blood;
tubocurarine, used to relax muscles during surgery (muscle relaxant), as ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER may enhance its effects;
barbiturates, which have a sedative effect on the central nervous system, used, for example, to treat epilepsy, or opioid analgesics, medicines used to reduce pain. These medicines may worsen dizziness upon standing due to low blood pressure (orthostatic hypotension);
medicines used to reduce blood fat levels, such as cholestyramine or colestipol resins, as they may reduce the absorption of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER;
medicines used to treat irregular heartbeat (antiarrhythmics such as quinidine, procainamide, amiodarone, sotalol), as they may cause heart rhythm problems (torsades de pointes);
medicines used to treat heart failure (digitalis medicines);
corticosteroids (which modulate anti-inflammatory responses) and adrenocorticotropic hormone (ACTH) (used to check adrenal gland function), as they may further reduce blood salt levels, particularly potassium (hypokalaemia);
pressor amines (e.g. noradrenaline), as ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER may reduce their effects;

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cancer treatments such as cyclophosphamide or methotrexate, as ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER may increase their toxicity;
medicines used to treat gout, such as allopurinol (see section “Warnings and precautions”);
immunosuppressive medicines; mTOR inhibitors (e.g. temsirolimus, sirolimus, everolimus), as concomitant administration may increase the risk of an allergic reaction called angioedema (see section “Stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER and inform your doctor if”);
a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan) or racecadotril. The risk of angioedema (swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) may be increased. See also information in sections “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER” and “Warnings and precautions”.

ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER and alcohol
ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER must not be taken with alcohol,
as excessive lowering of blood pressure may occur.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy (see section “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER”).
You must inform your doctor if you think you are pregnant (or if you are planning a pregnancy). Your doctor will advise you to stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER immediately before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER is not recommended for breastfeeding women, especially if your baby was born prematurely or during the first few weeks after delivery.
Driving and using machines
ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER may cause side effects that could affect your ability to drive or operate machinery, such as dizziness or fatigue, which may occur occasionally. Therefore, exercise caution when driving or operating machinery.
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ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is advisable to start therapy with ½ tablet daily. The recommended dose may then be increased to 1 tablet daily. If necessary, your doctor may increase the dose up to a maximum of 2 tablets once daily.

Previous diuretic therapy
If you are already taking another medicine that increases urine output (diuretic), the use of enalapril contained in ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER may cause an excessive reduction in blood pressure. In such cases, if your doctor considers it necessary to use ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER, they will instruct you to stop taking the diuretic for a few days before starting ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER. If this is not possible, your doctor will decide to start therapy with lower doses of enalapril, using separate tablets containing the same active ingredients as ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER (enalapril and hydrochlorothiazide). ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER may be used later, once your doctor has determined that you require the dose of enalapril and hydrochlorothiazide contained in one tablet of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER.

Patients with kidney problems (renal impairment)
Do not use ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER if you have severe kidney problems (see section “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER”).
If you have kidney problems, your doctor will monitor your kidney function and determine the appropriate dose of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER.

Use in children and adolescents
The use of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER is not recommended in children.

Use in the elderly
Dosage adjustment is not required in elderly patients.

If you take more ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER than you should
If you accidentally take too much ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER, contact your doctor immediately or go to the nearest hospital and stop the treatment.
Symptoms of overdose may include: feeling of emptiness in the head or dizziness due to excessive lowering of blood pressure, severe circulatory problems (circulatory shock), renal failure, hyperventilation, increased heart rate (tachycardia), palpitations, decreased heart rate (bradycardia), anxiety, cough, electrolyte disturbances such as low levels of potassium (hypokalaemia), chloride (hypochloraemia) and sodium (hyponatraemia) in the blood, and dehydration due to excessive diuresis.

If you forget to take ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER
Do not take a double dose to make up for the forgotten tablet.
If in doubt, contact your doctor or pharmacist.

If you stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER
Do not stop treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER unless instructed by your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER and consult your doctor immediately if, during treatment, you experience symptoms of angioedema, such as:

allergic reaction accompanied by swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat, leading to difficulty in swallowing or breathing (angioedema).

The side effects observed with the use of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER are:
Very common (may affect more than 1 in 10 people)

blurred vision;
dizziness;
cough;
nausea;
loss of strength (asthenia).

Common (may affect up to 1 in 10 people)

decrease in blood potassium levels (hypokalaemia) or increase in blood potassium levels (hyperkalaemia), increase in cholesterol, triglycerides, uric acid (hyperuricaemia) and creatinine levels in the blood;
headache (cephalalgia), depression, temporary loss of consciousness (syncope), altered taste;
lowering of blood pressure (hypotension), decrease in blood pressure following sudden change from sitting or lying down to standing position (orthostatic hypotension), changes in heart rhythm, chest pain with a sensation of tightness and pressure (angina pectoris), increased heart rate (tachycardia);
difficulty in breathing (dyspnoea);
diarrhoea, abdominal pain;
skin rash (exanthema);
involuntary muscle contractions (muscle cramps);
chest pain, fatigue.

Uncommon (may affect up to 1 in 100 people)

decrease in the number of red blood cells (anaemia, including aplastic and haemolytic anaemia);
decrease in blood sugar levels (hypoglycaemia), decrease in blood magnesium levels (hypomagnesaemia), pain and swelling in the joints (gout);
confusion, drowsiness, insomnia, nervousness, tingling sensation in the legs, arms or other parts of the body (paraesthesia), sensation of spinning (vertigo);
reduced sexual desire, impotence;
unpleasant sensation of ringing or buzzing in the ears (tinnitus);
redness and feeling of warmth, mainly in the face (flushing), awareness of irregular or forceful heartbeat (palpitations), heart attack (myocardial infarction) or stroke (cerebrovascular accident), possibly secondary to a sharp drop in blood pressure in high-risk patients (see section “Warnings and precautions”);
runny nose (rhinorrhoea), burning sensation in the throat (laryngodynia) and hoarseness, sensation of chest tightness making breathing difficult and noisy (bronchospasm/asthma);
reduced intestinal movements (ileus), inflammation of the pancreas (pancreatitis), vomiting, difficulty in digestion (dyspepsia), constipation (stipsis), loss of appetite (anorexia), stomach irritation, dry mouth, stomach lesions (peptic ulcer), increased production of intestinal gas (flatulence);
increased sweating (diaphoresis), itching, urticaria, hair loss (alopecia);
joint pain (arthralgia);
impaired kidney function, kidney failure, presence of protein in the urine (proteinuria);
malaise, fever;
increased blood urea levels (uraemia), low sodium concentration in the blood (hyponatraemia).

Rare (may affect up to 1 in 1,000 people)

decrease in the number of certain white blood cells (neutropenia, leucopenia and agranulocytosis), haemoglobin levels, total volume of red blood cells (low haematocrit), blood platelets (thrombocytopenia) or all different types of blood cells (pancytopenia), bone marrow depression (when the bone marrow fails to produce a sufficient number of blood cells), swelling of glands called lymph nodes (lymphadenopathy), diseases of the immune system (autoimmune diseases);
increased blood sugar levels;
abnormal dreams, sleep disturbances, partial reduction in mobility (paresis due to hypokalaemia);
reduced blood flow to the fingers of hands and feet causing redness and pain (Raynaud's phenomenon);
lung problems including pulmonary infiltrates, severe respiratory failure (respiratory distress syndrome), inflammation (pneumonitis) and fluid accumulation in the lungs (pulmonary oedema), allergic reaction (hypersensitivity) in the lungs (allergic alveolitis), lung disease (eosinophilic pneumonia);
irritation or inflammation of the nose (rhinitis);
inflammation of the mouth mucosa (stomatitis) with ulceration or aphthae, inflammation of the tongue (glossitis);
liver problems such as liver failure, liver damage (hepatic necrosis, potentially fatal), inflammation of the liver or bile ducts (hepatocellular or cholestatic hepatitis), yellowing of the skin and whites of the eyes (jaundice), inflammation of the gallbladder (cholecystitis, particularly in patients with pre-existing gallstones);
severe skin diseases with blister formation, redness and peeling, including erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus (an autoimmune disease causing skin inflammation), pemphigus and erythroderma (skin redness);
decreased urine output (oliguria), kidney disease (interstitial nephritis);
breast enlargement in men (gynaecomastia);
increased liver enzymes, increased bilirubin levels in the blood (bilirubinaemia).

Very rare (may affect up to 1 in 10,000 people)

increased calcium levels in the blood (hypercalcaemia);
swelling of the intestinal mucosa (intestinal angioedema);
acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from the available data)

syndrome of inappropriate antidiuretic hormone secretion (SIADH);
sudden onset of reduced distance vision (acute myopia);
decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
cancer of the skin and lips (non-melanoma skin cancer).

Other side effects
A complex disorder, with unknown frequency, including one or more of the following symptoms, has been reported:

fever, serositis (inflammation of the membranes lining body cavities such as chest and abdomen), vasculitis (inflammation of blood vessels), muscle pain or inflammation of muscles (myalgia/myositis), joint pain or inflammation (arthralgia/arthritis), positive test for antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), increased number of white blood cells (eosinophilia, leucocytosis), skin rash, skin sensitivity to light (photosensitivity) and other skin problems.

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Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ENALAPRIL E IDROCLOROTIAZIDE ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER contains

The active substances are: enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
The other components are: pregelatinized corn starch, sodium croscarmellose, monohydrate lactose, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172), sodium bicarbonate.

Description of the appearance of ENALAPRIL AND HYDROCHLOROTHIAZIDE ALTER and pack sizes
Pack of 14 divisible tablets.
Pack of 28 divisible tablets.
Marketing Authorization Holder
Laboratori Alter S.r.l., Via Egadi, 7 – 20144 Milano
Manufacturer
Balkanpharma Dupnitsa AD - 3 Samokovsko Shosse Str. - Dupnitsa 2600 - Bulgaria
Teva Pharmaceutical Works Private Limited Company (TPW Debrecen) - 13 Pallagi
street – 4042 Debrecen - Hungary
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Enalapril and hydrochlorothiazide Alter

Patient Information Leaflet